Evaluating the safety of LIFE-001 in healthy adults
A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001
This study is testing the safety of a new drug called LIFE-001 in healthy adults to see how well they can tolerate different doses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | LifeMine Therapeutics Industry-sponsored |
| Locations | 1 site (Bayswater, Victoria) |
| Trial ID | NCT06904807 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and tolerability of LIFE-001 in healthy adult volunteers. Participants will be assigned to either single ascending dose (SAD) or multiple ascending dose (MAD) cohorts, where they will receive varying doses of LIFE-001 or a placebo. The study involves a screening period followed by inpatient stays for monitoring after dosing. The doses will be adjusted based on safety and pharmacokinetic data collected from previous cohorts.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 who meet specific medical criteria.
Not a fit: Patients with significant medical issues or those taking certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety profile of LIFE-001, potentially leading to its use in future therapeutic applications.
How similar studies have performed: While this approach is common in early-phase trials, the specific compound LIFE-001 has not been tested in this manner before.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female or male between the ages of 18 and 65 years, inclusive * Medically healthy (without significant medical issues, e.g. high blood pressure) * Must provide written informed consent Exclusion Criteria: * Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant's safety or interfere with the absorption, distribution or excretion of the study drug * Any abnormal ECG findings, laboratory value or physical examination findings * Positive ethanol, drug screen or cotinine test * Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 7 days * Use of any experimental or investigational device within 30 days * Donation or loss of 500 mL or more of blood within 30 weeks and/or donation of plasma within 30 days
Where this trial is running
Bayswater, Victoria
- Veritus Research Pty Ltd — Bayswater, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Stephen Hall — Veritus Research
- Study coordinator: Simon Cooper
- Email: clinicaltrials@lifeminetx.com
- Phone: 617-665-5430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.